Effects of Virtual Reality and Nature Sounds on Pain and Anxiety in Women Having Cesarean Section

Not Applicable

Active, not recruiting

• Conditions: Obstetrics and Gynaecology; Nursing; Caesarean Section; Pain; Anxiety

• Registration Number: NCT06668428
• Lead Sponsor: Ondokuz Mayıs University

Brief Summary

This study will be conducted to determine the effects of virtual reality application on pain and anxiety in postpartum women after cesarean section. It will be applied to women who have had a cesarean section and who volunteered to participate in the study and were randomly assigned to intervention (n=40) and control (n=40) groups in a faculty hospital and a state hospital in Turkey. The use of virtual reality glasses will be taught to the postpartum women in the intervention group. After the initial mobilization, the postpartum women will be shown a nature view video with virtual reality glasses (VRG) accompanied by nature sounds for 20 minutes. The aim of this application is to enable women to watch nature images more effectively accompanied by nature sounds, thus allowing them to focus on the images and sounds, distract them, relax and remove them from the tension of the current environment. The application will be performed with the women in a semi-recumbent position and without sleeping. The same application will be applied to each woman and the glasses will be disinfected with Dermosept surface disinfectant, which provides cold sterilization, before the application. No application will be applied to the control group; only the general routine maintenance of the hospital will be performed. Data will be collected by the researcher through face-to-face interviews based on the statements of the women after cesarean section.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-30
• Study First Posted: 2024-10-31
• Study Start: 2024-12-24
• Primary Completion: 2025-03-17
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Volunteering to participate in the study
• Being over 18 years of ageBeing able to read and write in Turkish
• Giving birth at term, having a single, live and healthy baby
• The baby being with the mother
• Having a healthy/risk-free pregnancy
• Having had spinal anesthesia.

Exclusion Criteria

• Having a diagnosed psychiatric disease,
• Having a mental disability and communication problem,
• Having a vision or hearing problem,
• Developing complications during or after a cesarean section,
• Having any obstacles to postpartum mobilization.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
State Anxiety Level	Anxiety levels will be assessed 2 minutes before intervention and 2 minutes after the end of the intervention.	State anxiety level will be measured with Spielberger State Anxiety Scale. The Turkish reliability and validity study of the scale, which was developed by Spielberger and his colleagues to measure an individual's state and trait anxiety levels, was conducted by Öner and Le Compte in 1983. The scale examines anxiety in two sub-dimensions: State Anxiety measures an individual's feelings under a certain moment and condition, while Trait Anxiety expresses the individual's general anxiety level. Each statement in the scale is a 4-point Likert-type scale. There are 20 items in both types in the Spielberger State-Trait Anxiety Scale. The total score obtained from the scale varies between 20 and 80, with high scores indicating a high level of anxiety. The scale does not have any cut-off value. Cronbach's alpha coefficient was found to be 0.83 for State Anxiety.
Pain Level	Pain levels will be assessed 2 minutes before the intervention and 2 minutes after the end of the intervention.	Pain level will be measured with Visual Analog Scale. The use of the scale, developed by Price et al. in 1983, is achieved by measuring pain based on the statements of the people participating in the research. It is a one-dimensional, easy-to-administer scale and is widely used. It is a scale that the individual evaluates by making marks on a horizontal or vertical line of 10 cm or 100 mm, indicating that one end is very good and the other end is very poor. In our study, the scale starts with "mild pain" and ends with "very severe pain". A higher score from the scale indicates increased pain intensity.

Trial Locations

Locations (1)

Gynecology and Obstetrics Department affiliated to the Gynecology and Obstetrics Department of Samsun Education and Research Hospital; 🇹🇷 Samsun, Turkey